Effectiveness of Dextrose Pleurodesis for the Management of Post-Operative Air Leak

April 20, 2026 updated by: Olugbenga Okusanya, Thomas Jefferson University

Dextrose Pleurodesis Versus Standard of Care for the Management of Post-Operative Air Leak: A Single Center Prospective Trial

A common complication following lung resection surgery is the presence of a post-operative air leak. This occurs when the resected lung tissue does not seal adequately, resulting in continued leakage of air from the lung. For most patient, an air leak will self-resolve by maintaining a drainage catheter in the chest for a prolonged period. However, for some patients, additional measures are required to help seal the affected tissue. Known strategies for managing post-operative air leak include placing one-way valves, surgical revision, and chemical pleurodesis. Chemical pleurodesis involves injecting an irritant through the chest drainage catheter to promote sealing of the leaking lung tissue. While many agents exist for chemical pleurodesis, a relatively new method for treating an air leak is by using dextrose solution. Dextrose is appealing due to low cost and availability. Dextrose solution has shown some efficacy in other countries and undergone Phase 1 clinical investigation in Canada to show its safety and dosing recommendations. In this study, our aim is to compare the effectiveness of using dextrose solution for treating post-operative air leak compared to usual care with chest tube drainage alone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients who have undergone lung resection
  • Persistent post-operative air leak >24 hours after surgery with air leak >20 mL/min

Exclusion Criteria:

  • pregnant patients
  • incarcerated patients
  • patients with early post-operative complications
  • hemodynamic instability
  • need for mechanical ventilator support
  • high volume chest tube output (>750 mL over 24h)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextrose Pleurodesis
A one-time intrapleural administration of 150 mL dextrose solution will be administered
Drug: 50% Dextrose Pleurodesis
A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine
Other Names:
  • Dextrose
  • D50
Active Comparator: Standard of Care
Patients will maintain chest tube drainage system without additional intervention and air leak will be monitored
Other: Standard of Care Chest Drainage
maintenance of post operative pulmonary drain without additional intervention
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to air leak resolution
Time Frame: from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days
air leak <20mL/min as measured by digital tracking atrium
from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest tube duration
Time Frame: from randomization until chest tube removal, assessed up to 30 days
time until chest tube removal
from randomization until chest tube removal, assessed up to 30 days
Hospital Length of Stay
Time Frame: from randomization until hospital discharge, assessed up to 30 days
time until patient discharge
from randomization until hospital discharge, assessed up to 30 days
Adverse Events
Time Frame: from randomization through 30 days post-procedure
occurrence of complications including respiratory failure, pneumonia, and fever
from randomization through 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Olugbenga Okusanya, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJUH-iRISID-2025-0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will not be shared per internal IRB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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